Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00787-1
Product Name/Description BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4
(Nuclear medicine gamma camera and SPECT/CT diagnostic imaging systems)

Model numbers: 882478, 882482

ARTG numbers: 117642, 17440
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 14/06/2016
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue During a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. If this occurs, contact sensors would pause the scan. A certain set of conditions identified in the customer letter are required to create the situation.

There have been no reports of any injuries associated with this issue. However, users are reminded to ensure patients are observed closely at all times, and the E-Stop is activated to prevent contact with the patient, if required.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is providing users to instructions to follow in order to prevent the issue from occurring. A software upgrade will be implemented as a permanent correction.

August 2016 Update: Philips is providing an updated letter to users to provide clarity around the requirements for the situation to occur.

This action has been closed out on 08/11/2018
Contact Information 1800 251 400 - Philips Customer Care Centre